Method of implanting a penile prosthesis

ABSTRACT

A method of providing a patient having a predetermined corporotomy length with an implant having a length that is sized for the predetermined corporotomy length is disclosed. The method includes providing a penile implant having a delivered length that is approximately equal to the predetermined corporotomy length and comprising a distance that extends from a distal end of a distal tip to a proximal end of a proximal tip assembly, the proximal tip assembly providing a first proximal tip diameter. The method additionally includes reducing the first proximal tip diameter to a smaller implantable proximal tip diameter.

BACKGROUND

Penile implants provide relief for men with erectile dysfunction. In atypical implantation procedure, the penis of the patient is incised toexpose two corpora cavernosa that are aligned axially in a side-by-sideorientation within the penis. A corporotomy is formed that is sized toreceive the penile implant. For example, each corpora cavernosum isdilated proximally towards a crus of the penis and distally into theglans penis in a corporotomy procedure by introducing gradually largerstainless steel rods into the corpora cavernosum. The corporotomy thushas a length that extends between the crus of the penis and the glanspenis. The proximal portion of the corporotomy has a diameter that isapproximately the diameter of the largest stainless steel rod that thesurgeon was able to insert into the corpora cavernosum. A penile implantis selected that most nearly matches the length of the corporotomy and adiameter that most nearly matches the diameter of the proximal portionof the corporotomy.

Although the above-described approach has proven effective in treatingerectile dysfunction, the variety of different length and diameterpenile implants maintained in the inventory of the hospital can beprohibitively expensive.

SUMMARY

One aspect provides a penile implant including an inflatable bladderproviding a fluid chamber, a distal tip extending from a distal end ofthe inflatable bladder, and a proximal tip assembly extending from aproximal end of the inflatable bladder. The proximal tip assemblyincludes a tip core providing a first proximal tip diameter and a tipsleeve disposed over the tip core to provide a second proximal tipdiameter that is larger than the first proximal tip diameter. The tipsleeve is removable from the tip core to provide the penile implant witha proximal tip that is convertible between the first and second proximaltip diameters.

One aspect provides a method of providing a patient having apredetermined corporotomy length with an implant having a length that issized for the predetermined corporotomy length. The method includesproviding a penile implant having a delivered length that isapproximately equal to the predetermined corporotomy length andcomprising a distance that extends from a distal end of a distal tip toa proximal end of a proximal tip assembly, the proximal tip assemblyproviding a first proximal tip diameter. The method additionallyincludes reducing the first proximal tip diameter to a smallerimplantable proximal tip diameter.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of embodiments and are incorporated in and constitute apart of this specification. The drawings illustrate embodiments andtogether with the description serve to explain principles ofembodiments. Other embodiments and many of the intended advantages ofembodiments will be readily appreciated as they become better understoodby reference to the following detailed description. The elements of thedrawings are not necessarily to scale relative to each other. Likereference numerals designate corresponding similar parts.

FIG. 1A is an exploded side view and FIG. 1B is an assembled side viewof a conventional penile implant.

FIG. 2 is a side view of one embodiment of a penile implant with aproximal tip assembly having a tip sleeve that converts the proximal tipof the implant from a first narrower diameter to a second largerdiameter.

FIG. 3 is a perspective view of one embodiment of the tip sleeveillustrated in FIG. 2.

FIG. 4 is a side cross-sectional view of the tip sleeve illustrated inFIG. 3.

FIG. 5 is a side cross-sectional view of the tip sleeve attached to atip core of the penile implant illustrated in FIG. 2.

FIG. 6A is a top view and FIG. 6B is a cross-sectional view of a penisprepared to receive the penile implant illustrated in FIG. 2.

FIG. 6C is a top perspective view of the penile implant illustrated inFIG. 2 with the distal tip implanted into a corporotomy formed in thepenis.

DETAILED DESCRIPTION

In the following Detailed Description, reference is made to theaccompanying drawings, which form a part hereof, and in which is shownby way of illustration specific embodiments in which the invention maybe practiced. In this regard, directional terminology, such as “top,”“bottom,” “front,” “back,” “leading,” “trailing,” etc., is used withreference to the orientation of the Figure(s) being described. Becausecomponents of embodiments can be positioned in a number of differentorientations, the directional terminology is used for purposes ofillustration and is in no way limiting. It is to be understood thatother embodiments may be utilized and structural or logical changes maybe made without departing from the scope of the present invention. Thefollowing detailed description, therefore, is not to be taken in alimiting sense, and the scope of the present invention is defined by theappended claims.

It is to be understood that the features of the various exemplaryembodiments described herein may be combined with each other, unlessspecifically noted otherwise.

Soft tissue includes dermal tissue, sub-dermal tissue, ligaments,tendons, or membranes but does not include bone.

The term “proximal” as employed in this application means that part thatis situated next to or near the point of attachment or origin or acentral point: as located toward a center of the human body. The term“distal” as employed in this application means that part that issituated away from the point of attachment or origin or the centralpoint: as located away from the center of the human body. A distal endis the furthest endmost location of a distal portion of a thing beingdescribed, whereas a proximal end is the nearest endmost location of aproximal portion of the thing being described. For example, the glanspenis is located distal and of the crus of the penis is located proximalrelative to the male body such that a distal end of a corpora cavernosumof the patient extends about midway into the glans penis.

FIG. 1A is an exploded side view and FIG. 1B is an assembled side viewof a conventional penile implant 10. The conventional penile implant 10includes an inflatable cylinder 12 having a distal tip 14, a proximaltip 16, tubing 18 attached to the proximal tip 16 to inflate theinflatable cylinder 12 with liquid, and a rear tip extender 20 that isattachable to the proximal tip 16.

During an implantation procedure, the surgeon employs a tool to form anopening (a corporotomy) in the soft tissue of the corpora cavernosa ofthe penis. The corporotomy extends in a proximal direction into thepatient toward a crus of the penis and a distal direction toward theglans penis. The surgeon measures the length of the corporotomyextending between the crus and the glans penis and selects one of theabove-described conventional penile implants 10 having a length thatmost nearly approximates the measured length of the corporotomy. In somecases, the nearest length of the selected implant 10 is shorter than themeasured length of the corporotomy and the surgeon will add one or more“rear tip” extenders to lengthen the conventional penile implant 10.

Patients have different anatomical sizes. It is desirable to provide theconventional penile implant 10 with one or more rear tip extenders 20(RTEs 20) that offer additional length to better fit patients withlonger proximal corpora. To this end, the rear tip extender 20 isprovided in a variety of lengths from about 1-12 cm and is attachable tothe proximal tip 16 to extend an overall length of the conventionalpenile implant 10.

The RTEs 20 are attached to the penile implant 10 to add length to theimplant 10 and have a diameter that is always less that a diameter ofthe implant 10. The RTEs 20 do not allow the surgeon to scale theselected conventional penile implant 10 down to a suitable narrowerproximal diameter since the RTEs 20 lengthen the conventional penileimplant 10 without changing its diameter. Thus, RTEs 20 attached to theconventional penile implant 10 do not provide a solution if the surgeondetermines that the proximal portion of the corpora is narrower than thecorporotomy, for example due to fibrotic tissue growth or other physicalcharacteristics.

Embodiments provide a proximal tip assembly that extends from a proximalend of an inflatable bladder of a penile implant. The proximal tipassembly has a tip core that provides a first proximal tip diameter anda tip sleeve disposed over the tip core that provides a second proximaltip diameter that is larger than the first proximal tip diameter. Thetip sleeve is removable from the tip core to provide the penile implantwith a proximal tip that is convertible between the first and secondproximal tip diameters to allow the surgeon to selectively scale theimplant to accommodate a proximal portion of the corpora that isnarrower than the remaining corporotomy. Thus, in contrast to theconventional implant 10 with an RTE 20 that is attached to the penileimplant 10 to add length, embodiments described herein provide a tipsleeve that is removable from a rear tip of a penile implant to providean implant having a narrower implantable proximal tip.

Embodiments provide an implant having a delivered proximal tip diameterthat will accommodate a corporotomy having an approximately uniformdiameter by allowing the surgeon to employ the proximal tip assemblywith the tip sleeve in place over the tip core, and alternatively, thatwill accommodate a proximal portion of the corpora that is narrower thanthe remaining corporotomy by removing the tip sleeve from the tip coreto present an implantable proximal tip diameter that is smaller than thedelivered proximal tip diameter.

FIG. 2 is a side view of one embodiment of a penile implant 50 providedwith a convertible proximal tip assembly 52. The penile implants 50includes an inflatable bladder 54 providing a fluid chamber 56, a distaltip 58 extending from a distal and 60 of the inflatable bladder 54,where the proximal tip assembly 52 extends from a proximal and 62 of theinflatable bladder 54. The proximal tip assembly 52 includes a tip core64 that provides a first proximal tip diameter D1 and a tip sleeve 66disposed over the tip core 64 to provide a second proximal tip diameterD2 that is larger than D1. The tip sleeve 66 is removable from the tipcore 64 to provide the implant of 50 with a proximal tip that isconvertible between the first and second proximal tip diameters D1, D2.Tubing 68 is attached to the proximal tip assembly 52 and communicateswith the fluid chamber 56. The tubing 68 provides a conduit 68 thatcommunicates with a fluid reservoir (not shown), where the fluidreservoir provides a repository for the fluid that is employed toinflate the inflatable bladder 54.

The inflatable bladder 54 is generally provided as an oblong cylinderthat is closed and sealed and thus configured to be inflated when fluid(e.g., saline typically, or a gas) is introduced into the tubing 68. Ingeneral, it is desirable to deflate the inflatable bladder 54 inpreparation for implantation of the implant 50 into the penis, since thedeflated bladder 54 is easier to insert into the corporotomy formed inthe corpora cavernosum. The bladder 54 is configured to be subsequentlyinflated by the surgeon to ensure performance of implant 50, and laterafter healing by the patient to achieve an erection.

In one embodiment, the inflatable bladder 54 is fabricated from aurethane material sold under the trademark Bioflex and is available fromColoplast Corp., Minneapolis, Minn.

The distal tip 58 is attached to the distal end 60 of the inflatablebladder 54. In one embodiment, the distal tip 58 is formed fromsilicone, which is dissimilar to the urethane material of the Bioflexinflatable bladder 54. To facilitate the attachment of these twodissimilar materials, in one embodiment the urethane material of theinflatable bladder 54 is coated with fumed silica to prepare theurethane surface for bonding with the silicone tip 58. Alternatively, inone embodiment the distal tip 58 is integrally formed to extend from thedistal end 60 of the inflatable bladder 54 as a one-piece unit.

The proximal tip core 64 is attached to the proximal end 62 of theinflatable bladder 54. In one embodiment, the tip core 64 is fabricatedfrom silicone and is permanently connected to the proximal end 62 two ofthe inflatable bladder 54.

In one embodiment, the distal tip 58 and the proximal tip core 64 areintegrally formed with the inflatable bladder 54 to provide a monolithicpenile prosthesis, where the tip sleeve 66 is removable from themonolithic penile prosthesis.

FIG. 3 is a perspective view and FIG. 4 is a cross-sectional view of thetip sleeve 66. In one embodiment, a distal end 70 of the tip sleeve 66provides an attachment ring 72 that is sized to seat and engage around adistal end of the proximal tip core 64. In one embodiment, the tipsleeve 66 forms a recess 74 extending in a proximal direction from thedistal end 70 that is sized to receive the conduit 68 when theattachment ring 70 is engaged around the proximal tip core 74. The tipsleeve 66 is formed to have a thickness T such that the diameter D2 isgreater than the diameter D1 by a factor of 2T. In one embodiment, thethickness T is between approximately 0.5-2 mm. The tip sleeve 66 issuitably fabricated from a polymer material, one suitable example ofwhich is silicone.

FIG. 5 is a side cross-sectional view of the tip sleeve 66 attached tothe tip core 64 of the penile implant 50. The tip core 64 has acircumferential groove formed around a periphery of its outer surfaceand the engagement ring 72 is coupled with the groove that is adjacentto the proximal end 62 of the inflatable bladder 54. Thus, in oneembodiment the sleeve 66 is friction-fit to the tip core 64 and isretained by the engagement ring 72 that seats within the groove of thetip core 64.

In one embodiment, an interior surface of the sleeve 66 is coated withadhesive to allow the sleeve 66 to be adhesively attached to the tipcore 64. In one embodiment, at least the interior surface of the sleeve66 is formed of a material that is compatible with the tip core 64 toallow the sleeve 66 to be cohesively attached to the tip core 64.

The tip sleeve 66 increases the diameter of the tip core 64 from thediameter D1 to the diameter D2, which in this example is approximately2T. For example, in the case where the thickness T is about 1 mm, thediameter D1 increases from 10 mm to the diameter D2 of 12 mm, and theoverall length of the penile implant 50 increases in a minimal fashionby 1 mm. The tip sleeve 66 has a minimal or no effect on the length ofthe tip core 64. For example, the tip core 64 provides a first proximaltip length and the tip sleeve 66, when attached over the tip core 64,provides the tip assembly 52 with a second proximal tip length that issubstantially the same (within 1-5 mm) as the first proximal tip length.In contrast, attachment of the rear tip extender 20 (FIG. 1) increasesthe length of implant by about 3 cm, or by a factor of about 30 over thetip sleeve 66.

An overall proximal height H of the rear tip assembly 52 is measuredfrom an edge of the conduit 68 to an outside surface of the tip sleeve66. In one embodiment, the conduit 66 is provided as a “zero angle”tubing and the proximal height H is about 18 mm for a thickness T of thetip sleeve 66 of about 1 mm.

FIG. 6A is a top view and FIG. 6B is a cross-sectional view of a penis Pprepared to receive the penile implant 50. The corpora cavernosa areillustrated as C1 and C2, where the corpora cavernosum C1 of FIG. 6B hasbeen opened in a corporotomy procedure to a size that is suited toreceive penile implant 50.

The groin area 100 of the patient is shaved, cleaned and suitablyprepped with a surgical solution prior to draping with a sterile drapeas directed by the healthcare provider's procedures. A retractiondevice, such as a retractor 102 sold under the trademark Lone Star andavailable from Lone Star Medical Products of Stafford, Tex., is placedaround the penis P if so desired by the surgeon to establish asurgically clean field. A catheter 103 is inserted into the urethra Ufrom the distal end 104 of the penis P. Thereafter, the surgeon forms anincision to access the corpora cavernosa C1 and C2 of the penis.

Suitable examples of incisions include either an infrapubic incision ora transverse scrotal incision. The infrapubic incision is initiatedbetween the umbilicus and the penis (i.e., above the penis), whereas thetransverse scrotal incision is made across an upper portion of thepatient's scrotum Sc.

As an example of the transverse scrotal approach, with reference to FIG.6B, the surgeon forms a 2-3 cm transverse incision through thesubcutaneous tissue of the median raphe of the upper scrotum Sc anddissects down through the Darto's fascia Df and Buck's fascia Bf toexpose the tunicae albuginea TA of the penis P. Thereafter, each corporacavernosum C1 and C2 is exposed in a corporotomy where a small(approximately 1.5 cm) incision is formed through the tissue and thefascia to allow the surgeon to access and subsequently dilate thecorpora cavernosa C1 and C2.

In the illustrated example, the penis P is reclined against the torsosuch that the urethra U, surrounded by corpus spongiosum tissue, isoriented upward. A corporotomy tool, for example a cavernatome (notshown), is introduced into the exposed the corpora cavernosa (C1 and C2)to remove (e.g., “core out”) the corpora cavernosum C1 proximally anddistally. With reference to both FIGS. 6A and 6B, the surgeon typicallywill insert a blunt-ended scissors or other elongated tool to separate aportion of the spongiosum material to open a pathway for thecavernatome. Thereafter, the cavernatome is manipulated within eachcorpora cavernosum C1 and C2 distally and proximally with sequentiallylarger diameters until the corporotomy provides an opening of about 10mm.

A length of the corporotomy is measured from the crus of the penisproximately to a mid-glans location of the penis distally. The surgeoninserts the shaft of the cavernatome into the corporotomy to measure theproximal and distal length of each corpora cavernosum C1 and C2. Forexample, the shaft is inserted into one of the corpora cavernosa C1 orC2 forward in the distal penis toward the glans penis, the distalmeasurement is recorded, and the shaft is inserted into the same corporacavernosum C1 or C2 rearward in the proximal penis toward the crus ofthe penis to record the proximal length of the corpora. The distal andproximal measurements would typically be made in reference to a “staystitch” (not shown) temporarily placed in the incision. The sum of thedistal and the proximal measurements represent the length of thecorporotomy into which the implant 50 (FIG. 2) is placed. This procedureis repeated for the other of the corpora cavernosa C1 or C2 to measurethe length of the companion corpora.

Different patients have different anatomy. Some patients will presentwith fibrotic proximal corpora that have a diameter that is narrowerthan a diameter of the remaining corporotomy. For example, some patientswill have a penile implant that requires replacement. Upon removal(explant) of the penile implant the surgeon will discover that theproximal corporotomy toward the crus of the penis has become fibroticand difficult to open.

With reference to FIG. 2 and FIG. 6, the implant 50 provides a firstproximal tip diameter D2 that is suitable for implanting into a patientwith an approximately uniform corporotomy. In addition, the implant 50provides a removable tip sleeve 66 that can be removed to expose the tipcore 64 having a second implantable proximal tip diameter D1 that isnarrower than the first proximal tip diameter D2. The implant 50 thusprovides the surgeon with a convertible proximal tip that can beconverted between the larger first proximal tip diameter D2 and thesmaller second proximal tip diameter D1. In this regard, the proximaltip assembly 52 has a delivered proximal tip diameter D2 (FIG. 2) andthe tip sleeve 66 is removable from the tip core 64 to provide animplantable proximal tip diameter D1 that is smaller than the deliveredproximal tip diameter D2. In one embodiment, the sleeve 66 providesmeans for converting the proximal tip assembly 52 to an implantableproximal tip diameter D1 that is smaller than the first/deliveredproximal tip diameter D2 without significantly altering or increasingthe length of the tip assembly 52.

As illustrated in FIG. 6C, the sleeve 66 has been removed to expose theproximal tip core 64 having the narrower proximal tip diameter D1 thatis configured to accommodate a patient with a narrower proximalcorporotomy.

In one embodiment, a method of providing a patient having apredetermined corporotomy length with an implant having a length that issized for the predetermined corporotomy length includes: providing apenile implant 50 having a delivered length that is approximately equalto the predetermined corporotomy length and having a distance thatextends from a distal end of a distal tip 58 to a proximal end of aproximal tip assembly 52, the proximal tip assembly 52 providing a firstproximal tip diameter D2; and reducing the first proximal tip diameterD2 to a smaller implantable proximal tip diameter D1.

After insertion of the implant 50 the corporotomy is closed and theremaining portions of the penile prosthetic device, for example areservoir and/or a pump, are implanted in the abdomen and scrotum S,respectively, of the patient.

Although specific embodiments have been illustrated and describedherein, it will be appreciated by those of ordinary skill in the artthat a variety of alternate and/or equivalent implementations may besubstituted for the specific embodiments shown and described withoutdeparting from the scope of the present invention. This application isintended to cover any adaptations or variations of medical devices asdiscussed herein. Therefore, it is intended that this invention belimited only by the claims and the equivalents thereof.

1. A method of providing a patient having a predetermined corporotomylength with an implant having a length that is sized for thepredetermined corporotomy length, the method comprising: providing apenile implant having a length that is approximately equal to thepredetermined corporotomy length and comprising a distance that extendsfrom a distal end of a distal tip to a proximal end of a proximal tipassembly, the proximal tip assembly providing a first proximal tipdiameter; and reducing the first proximal tip diameter to a smallerimplantable proximal tip diameter by removing a tip sleeve of theproximal tip assembly and exposing a tip core of the proximal tipassembly while leaving the length of the penile implant substantiallyunchanged.
 2. The method of claim 1, wherein removing a tip sleeve ofthe proximal tip assembly comprises peeling a tip sleeve that isadhesively attached to a tip core of the proximal tip assembly.
 3. Themethod of claim 1, wherein removing a tip sleeve of the proximal tipassembly comprises peeling a tip sleeve that is cohesively attached to atip core of the proximal tip assembly.
 4. The method of claim 1, whereinremoving a tip sleeve of the proximal tip assembly comprises detaching adistal end of a tip sleeve that is mechanically attached to a distal endof a tip core of the proximal tip assembly.
 5. A method of claim 1, themethod further comprising: forming a corporotomy in a corpora cavernosumof a penis; and determining a maximum width of a proximal corpora of thecorporotomy formed in the penis.